BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Quality Mix Blender, Oxymixer

    K Number: K221494 · Decision Jan 23, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    245

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    Basic Information

    Device Name
    Quality Mix Blender, Oxymixer
    K Number
    K221494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5330
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dehas Medical Systems GmbH
    Date Received
    May 23, 2022
    Decision Date
    January 23, 2023
    Product Code
    BZR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BZR Mixer, Breathing Gases, Anesthesia Inhalation

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    Other Clearances by Dehas Medical Systems GmbH

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